StrokeNCT04931628
Efficacy and Safety of Salvianolic Acid on AIS
A study testing Salvianolic Acid and 0.9% NaCl in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Salvianolic Acid and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2023to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;
- CT examination to rule out cerebral hemorrhage;
- With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4
Who cannot join
- Diseases with bleeding tendency;
- Liver and kidney dysfunction;
- Malignant tumors or those undergoing anti-tumor treatment;
- Allergic physique, allergic to aspirin or Salvianolic Acid;
- Heart failure, multiple system failure;
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis.
Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system.
The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.
- Conditions
- Stroke
- Being tested
- Salvianolic Acid, 0.9% NaCl
- Keywords
- Stroke, ischemic, Acute
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvianolic AcidDrug
salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days
0.9% NaClDrug
0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| salvianolic acid group | Active comparator | salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days Receives: Drug: Salvianolic Acid |
| 0.9% NaCl | Placebo comparator | 0.9%NaCl 250ml, injection, 14 days Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRS score
MRS score ≤2
Measured: 90 days
Secondary outcomes (4)
Cerebral blood flow volume (CBV)
Cerebral blood flow volume
Measured: 90 days
Cerebral blood flow (CBF)
Cerebral blood flow
Measured: 90 days
NIHSS score
NIHSS score
Measured: 90 days
Adverse drug reactions (ADR)
Adverse drug reactions
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start3 Feb 2023
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Why it stopped: negative information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Ningbo No. 1 Hospital, Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xiaoshan People's Hospital, Red Cross Hospital, Hangzhou, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931628
- Sponsor's protocol ID
- 2017-092
- Status last verified
- Feb 2023
- First submitted
- 14 Jun 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04931628
- Acronym / sponsor ID
- 2017-092
- Conditions
- Stroke
- Keywords
- Stroke, ischemic, Acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: negative information
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Ningbo No. 1 Hospital, Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xiaoshan People's Hospital, Red Cross Hospital, Hangzhou, China
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis.
Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system.
The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salvianolic acid group | Active comparator | Drug: Salvianolic Acidsalvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days |
| 0.9% NaCl | Placebo comparator | Drug: 0.9% NaCl0.9%NaCl 250ml, injection, 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;
- CT examination to rule out cerebral hemorrhage;
- With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4
Key exclusion criteria (6 listed)
- Diseases with bleeding tendency;
- Liver and kidney dysfunction;
- Malignant tumors or those undergoing anti-tumor treatment;
- Allergic physique, allergic to aspirin or Salvianolic Acid;
- Heart failure, multiple system failure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvianolic Acidsalvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days | Drug | salvianolic acid group |
| 0.9% NaCl0.9% NaCl | Drug | 0.9% NaCl |
Primary outcome
MRS score
Time frame: 90 days
MRS score ≤2
4 secondary outcomes
Cerebral blood flow volume (CBV)
Time frame: 90 days
Cerebral blood flow (CBF)
Time frame: 90 days
NIHSS score
Time frame: 90 days
Adverse drug reactions (ADR)
Time frame: 90 days
Results and safety
The study was stopped early (reason given: negative information). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salvianolic Acid and 0.9% NaCl in people with Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: negative information). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRS score (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.